Acute Ischemic StrokePhase 4HeparinasNCT01862978
Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
A Phase 4 study testing Heparin and Nadroparin in people with Acute Ischemic Stroke, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Heparin and Nadroparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSlovakia
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke
- female or male gender
- mRS (modified Rankin Scale) 0-1 (min one month before the event)
- NIHSS ≥ 6 and ≤ 25
- Age: 18-80 years
- initiation of therapy in the interval from 4.5 to 24 hours from onset of symptoms of ischemic stroke
Show all 10Show fewer
- focal neurological deficit of at least 30 min, which was significantly obviously does not disappear before treatment
- patient will participate voluntarily and signed informed consent. Informed consent will be obtained from each patient, guardian or close relative
- patients who are unable to sign, but who are able to understand what means to participate in the study, may give informed consent through eyewitness
- willingness and ability to comply with the protocol
Who cannot join
- intracranial hemorrhage confirmed by CT scan
- CT image heavy and extensive focal cerebral ischemia
- lacunar syndrome
- epileptic seizure at the beginning of ischemic stroke
- previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis
- stroke, myocardial infarction, head trauma in the last 3 months
Show all 19Show fewer
- tromboctov count below 100 000/mm ³
- therapeutically uncontrolled blood pressure: systolic blood pressure> 185 mmHg or diastolic blood pressure> 110 mmHg
- therapeutically uncontrolled blood glucose ˂ 2.77 or> 22.15 mmol / l
- Known bleeding diathesis, other coagulopathies, severe hepatopathy, severe nephropathy
- patients receiving oral anticoagulants
- current or previous life-threatening bleeding
- major surgery less than 2 weeks ago
- known malignancy
- active TB
- pregnancy
- allergy to Heparin or Fraxiparine
- known alcohol abuse and / or drugs
- active participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Neurology Clinic Univeristy Hospital in Martin
Martin, 03659
Jana Dluha, MD, +421905514377, jana.dluha@gmail.com
Vladimir Nosal, MD, PhD
About this study
Official title: Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours.
Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose.
Read more
Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended.
The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose.
All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.
For initiation of treatment will be assessed:
- Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria
- Sign the informed consent and patient randomization
- Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation
- Women of childbearing age (pregnancy test)
- History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.).
- Initial CT examination of the brain
- EKG
- USG sections of extracranial carotid and vertebral arteries
- special hematology factors
If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions.
After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally.
In the interval from 24 to 30 hours of starting treatment the patient will be made:
- Control CT brain
- EKG
- Basic coagulation
- Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan
- special hematology factors 72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index.
Safety endpoints: mortality, adverse side effects, bleeding
- Conditions
- Acute Ischemic Stroke
- Being tested
- Heparin, Nadroparin, Placebo
- Keywords
- Stroke, Heparin, Nadroparin
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
NadroparinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Experimental | Patient receiving Heparin Receives: Drug: Heparin; Drug: Placebo |
| Nadroparin | Experimental | Patient receiving nadroparin Receives: Drug: Nadroparin; Drug: Placebo |
| Placebo | Placebo comparator | Patients receiving placebo Receives: Drug: Heparin; Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of nadroparine or heparin
Safety - incidence of intracranial hemorhage
Measured: DAY 3,7,30,90
Efficacy of nadroparine or heparin
Efficacy -level of improvement measured by mRS, and NIHSS
Measured: DAY 3,7, 30, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Nosal, MD, PhD, University Hospital, Martin
- Investigators
- Vladimir Nosal, MD, PhD, Principal investigator, Jessenius Faculty of MedicineEgon Kurca, MD, PhD, prof, Study director, Jessenius Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862978
- Sponsor's protocol ID
- MTSVKNEUROL001
- Acronym
- Heparinas
- Status last verified
- Aug 2013
- First submitted
- 20 May 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dluha J, Sivak S, Kurca E, Dusenka R, Kalmarova K, Turcanova Koprusakova M, Kantorova E, Nosal V. The safety and efficacy of Heparin and Nadroparin compared to placebo in acute ischemic stroke - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Dec;160(4):543-548. doi: 10.5507/bp.2016.042. Epub 2016 Sep 19.
PubMed 27646496
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01862978
- Acronym / sponsor ID
- Heparinas / MTSVKNEUROL001
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Heparin, Nadroparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours.
Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose.
Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended.
The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose.
All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.
For initiation of treatment will be assessed:
- Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria
- Sign the informed consent and patient randomization
- Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation
- Women of childbearing age (pregnancy test)
- History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.).
- Initial CT examination of the brain
- EKG
- USG sections of extracranial carotid and vertebral arteries
- special hematology factors
If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions.
After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally.
In the interval from 24 to 30 hours of starting treatment the patient will be made:
- Control CT brain
- EKG
- Basic coagulation
- Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan
- special hematology factors 72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index.
Safety endpoints: mortality, adverse side effects, bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heparin | Experimental | Drug: Heparin, Drug: PlaceboPatient receiving Heparin |
| Nadroparin | Experimental | Drug: Nadroparin, Drug: PlaceboPatient receiving nadroparin |
| Placebo | Placebo comparator | Drug: Heparin, Drug: NadroparinPatients receiving placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ischemic stroke
- female or male gender
- mRS (modified Rankin Scale) 0-1 (min one month before the event)
- NIHSS ≥ 6 and ≤ 25
- Age: 18-80 years
Key exclusion criteria (19 listed)
- intracranial hemorrhage confirmed by CT scan
- CT image heavy and extensive focal cerebral ischemia
- lacunar syndrome
- epileptic seizure at the beginning of ischemic stroke
- previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin | Drug | Heparin, Placebo |
| Nadroparin | Drug | Nadroparin, Placebo |
| Placebo | Drug | Heparin, Nadroparin |
Primary outcome
Safety of nadroparine or heparin
Time frame: DAY 3,7,30,90
Safety - incidence of intracranial hemorhage
Efficacy of nadroparine or heparin
Time frame: DAY 3,7, 30, 90
Efficacy -level of improvement measured by mRS, and NIHSS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Derived from this study: PubMed 27646496Dluha J, Sivak S, Kurca E, Dusenka R, Kalmarova K, Turcanova Koprusakova M, Kantorova E, Nosal V. The safety and efficacy of Heparin and Nadroparin compared to placebo in acute ischemic stroke - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Dec;160(4):543-548. doi: 10.5507/bp.2016.042. Epub 2016 Sep 19.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Nosal, MD, PhD principal investigator
Jessenius Faculty of Medicine
Egon Kurca, MD, PhD, prof study director
Jessenius Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin and Nadroparin in people with Acute Ischemic Stroke, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Nosal, MD, PhD (+421905764991, vnosal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of nadroparine or heparin (time frame: DAY 3,7,30,90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.